Identity
- Trade Name
- Eroxon FDA UDI
- Generic Name
- Penile cooling/warming gel FDA UDI
- Device Name
- Eight single-use tubes of Eroxon gel in one carton. FDA UDI
- Model / Reference
- Eight Pack FDA UDI
- Description
- Eight single-use tubes of Eroxon gel in one carton. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00307663076091 FDA UDI
- 510(k) Number
- DEN220078 FDA UDI
- FDA Product Code
- QWW FDA UDI
- GMDN Term
- Penile cooling/warming gel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5021 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Penile cooling/warming gel
Eroxon by Haleon US Holdings LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Penile cooling/warming gel.
- Eroxon — LIL DRUG STORE PRODUCTS, INC. · Class II
- Eroxon — Haleon US Holdings LLC · Class II
Cleared under the same submission
DEN220078 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Haleon US Holdings LLC
Sources (1)
- FDA UDI a9789bcb-dcd8-4462-acee-fd2415349d41 34 fields · synced Jun 6, 2026